FDA Guidance for Industry: How to Prepare a PreRequest for Designation (Pre-RFD)
Titel:
FDA Guidance for Industry: How to Prepare a PreRequest for Designation (Pre-RFD)
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance is intended to assist sponsors in obtaining a preliminary assessment from the U.S. Food and Drug Administration (FDA or Agency) through the Pre-Request for Designation (PreRFD) process.